21 CFR § 522.1338 - Medetomidine and vatinoxan.
---
identifier: "/us/cfr/t21/s522.1338"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1338 - Medetomidine and vatinoxan."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1338"
section_name: "Medetomidine and vatinoxan."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---
# 522.1338 Medetomidine and vatinoxan.
(a) *Specifications.* Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
(b) *Sponsor.* See No. 043264 in § 510.600(c) of this chapter.
(c) *Conditions of use*—(1) *Amount.* Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m
<sup>2</sup>) BSA or use the dosing table provided in labeling.
(2) *Indications for use.* For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]